Global Hemoglobin A1c (HbA1c) Testing Markets

2013-03-26
Published : Mar-2013

Hemoglobin A1c (HbA1c) testing is the most recent major technology to have entered the diabetes testing market. As the global prevalence of diabetes mellitus continues to increase rapidly, with more than 366 million diabetics worldwide, hemoglobin A1c testing is now an essential assay in the diabetes testing repertoire. Its clinical utility and improvements in its accuracy and implementation of standardized protocols have translated into continued market growth. This TriMark Publications report describes the specific market segment that encompasses hemoglobin A1c testing for diagnosing and monitoring diabetes. The study reviews all of the generally accepted clinical analytical methods that are currently in use today for measuring HbA1c levels. Moreover, it examines clinical measurement devices and reagents as utilized in hospitals, clinics, doctor’s offices and at-home care locations. The report also analyzes almost all of the companies known to be marketing, manufacturing or developing hemoglobin A1c testing. Detailed tables and charts with sales forecasts and marketshare data are also included.

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Table of Contents:

3. Market Analysis: Size, Growth, Share and Competitors 
3.1 Worldwide HbA1c Testing Market 39
3.1.1 U.S. HbA1c Testing Market 40
3.2 HbA1c Self-Testing Market 41
3.3 Competitive Situation 43
3.3.1 Analyses of the Key Players, Current Market Conditions, and Product Mix 43
3.3.2 Competitive Strategies and Strategic Recommendations 44
3.3.3 Future Competing Technologies—Glycated Albumin 45
3.4 Market Drivers and Restraints 46
3.4.1 Market Drivers 46
3.4.2 Market Restraints 46
3.5 Market and Product Trends 47
3.5.1 Increase in POC AC1 Testing 47
3.5.2 Move Towards Screening for Diabetes Using HbA1c Assays 48
3.6 Adjacent Markets 48

4. Overview of HbA1c Testing 
4.1 Technology Platforms Used to Measure HbA1c 50
4.1.1 High-Performance Liquid Chromatography (HPLC) 50
4.1.2 Immunoassays 50
4.1.3 Boronate Affinity Chromatography 50
4.1.4 Enzymatic Assay 51
4.1.5 Micro-Optical Detection Methods 51
4.2 Development of HbA1c Testing: A Historical Evaluation 51
4.2.1 The Diabetes Control and Complications Trial (DCCT) 51
4.3 Standardization of HbA1c Testing and Certification Criteria 52
4.3.1 National Glycohemoglobin Standardization Program (NGSP) 52
4.3.2 International Federation of Clinical Chemistry (IFCC) 53
4.3.3 New NGSP Certification Criteria Beginning in September 53
4.3.4 ADAG (A1c Derived Average Glucose) 53
4.3.5 2010 Consensus Statement on the Worldwide Standardization of HbA1c 53
4.3.6 College of American Pathologists (CAP) Proficiency Program 54
4.3.7 Certifications and Selecting HbA1c Assays 54
4.4 Advantages and Disadvantages of HbA1c Assessment 54
4.5 HbA1c Testing Recommendations 56
4.5.1 Frequency of HbA1c Testing 56
4.5.2 Diagnostic HbA1c Testing 57
4.5.3 Screening for Pre-diabetes 59
4.5.4 HbA1c Testing for Diabetes Management and Glycemic Goals 59
4.6 Accuracy and Precision in HbA1c Testing 60
4.6.1 Biological Variation 60
4.6.2 Pre-Analytical Variation 61
4.6.3 Analytical Variation 61
4.7 Potential Interfering Variables Affecting HbA1c Testing 63
4.8 Potential Areas of Improvement in HbA1c Testing Performance 64
4.9 Optimizing of Point of Care (POC) HbA1c Testing 65
4.10 Key Issues for HbA1c Testing 65
4.11 HbA1c Testing and Blood Glucose Testing: Complementary Tools 66

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